TRiBE: TB PCR in BAL and EBUS-TBNA
Research type
Research Study
Full title
Xpert MTB/RIF Ultra assay for the detection of Mycobacterium tuberculosis (MTB) in bronchoalveolar lavage (BAL) for pulmonary TB and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) samples for mediastinal TB.
IRAS ID
266798
Contact name
Onn Min Kon
Contact email
Sponsor organisation
Imperial College London and Imperial College Healthcare NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 15 days
Research summary
This prospective observational multi-centre UK study will evaluate Xpert MTB/RIF Ultra for the detection of tuberculosis in bronchoalveolar lavage (BAL) samples for pulmonary TB and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) samples for lymph node TB. The diagnostic accuracy of the test will be compared to other current conventional tests (smear, culture, cytology).
The performance of Xpert Ultra will be assessed by calculating the sensitivity, specificity, positive predictive and negative predictive value. The turn-around time of all various methods of TB diagnosis will be measured, and the ensuing effect on treatment decisions assessed. Finally, we will analyse the ‘Trace’ readings from Xpert Ultra and describe the clinical characteristics of the patients with these readings.
REC name
South East Scotland REC 01
REC reference
20/SS/0089
Date of REC Opinion
7 Oct 2020
REC opinion
Further Information Favourable Opinion